Clinical Trials List
2017-03-03 - 2023-02-28
Phase III
Terminated18
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-9571.8
Other chronic nonalcoholic liver disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
-
Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
-
Sponsor
Gilead Sciences
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 曾志偉 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hung-Wei Wang Division of General Internal Medicine
- Hsueh-Chou Lai Division of General Internal Medicine
- Wei-Fan Hsu Division of General Internal Medicine
- 蘇文邦 Division of General Internal Medicine
- 陳昇弘 Division of General Internal Medicine
- Po-Heng Chuang Division of General Internal Medicine
- Hung-Yao Chen Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- TENG-YU LEE Division of General Internal Medicine
- CHUNG-HSIN CHANG Division of General Internal Medicine
- 呂宜達 Division of General Internal Medicine
- 廖思嘉 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林崇棋 Division of General Internal Medicine
- Chien-Wei Su Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蘇培元 Division of General Internal Medicine
- 鄭畬方 Division of General Internal Medicine
- 徐友春 Division of General Internal Medicine
- 王舒儀 Division of General Internal Medicine
- 吳順生 Division of General Internal Medicine
- 杜思德 Division of General Internal Medicine
- 林彥至 Division of General Internal Medicine
- 蘇矢立 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳立偉 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 簡世杰 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
- 邱彥程 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
- Chien-Hao Huang Division of General Internal Medicine
- Yi-Chung Hsieh Division of General Internal Medicine
- 陳威廷 Division of General Internal Medicine
- 滕威 Division of General Internal Medicine
- 曾振輝 Division of General Internal Medicine
- Yi-Cheng Chen Division of General Internal Medicine
- Wen-Juei Jeng Division of General Internal Medicine
- 鄭雅婷 Division of General Internal Medicine
- 何玉彬 Division of General Internal Medicine
- Chun-Yen Lin Division of General Internal Medicine
- 李承翰 Division of General Internal Medicine
- 戴達英 Division of General Internal Medicine
- Rong-Nan Chien Division of General Internal Medicine
- Chen-Chun Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Chen-Hua Liu Digestive System Department
- 楊宏志 Digestive System Department
- Kuo-Chin Huang Division of Family Medicine
- Chun-Jen Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wan-Long Chuang Division of General Internal Medicine
- 黃駿逸 Division of General Internal Medicine
- Ming-Lung Yu Division of General Internal Medicine
- Chia-Yen Dai Division of General Internal Medicine
- Chung-Feng Huang Division of General Internal Medicine
- Ming-Lun Yeh Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
A stratified Mantel-Haenszel (MH) test will be used to compare the
differences in proportion of subjects who achieve a ≥ 1-stage
improvement in fibrosis without worsening of NASH at Week 48
between each of the SEL arms and the placebo arm, adjusting for
stratification factors. The point estimates and 95% confidence intervals
for the differences in proportions will be calculated.
Clinical Endpoint Analysis:
The clinical efficacy endpoint at Week 240 is EFS. EFS will be assessed
by time to the first clinical event in the Randomized Phase. Differences
in time to the first clinical events between each of the SEL arms and the
placebo arm will be assessed using the stratified log-rank test. The
clinical efficacy endpoint will only be evaluated at Week 240 for the SEL
arm if the SEL arm demonstrates superiority for the primary efficacy
endpoint at Week 48.
Secondary Efficacy Endpoint Analyses:
A stratified MH test will be performed to compare the differences in
proportions between each SEL treatment arm and the placebo arm for the
following endpoints:
• Proportion of subjects who have progression to cirrhosis by Week 48;
• Proportion of subjects who have a ≥ 1-stage improvement in fibrosis
without worsening of NASH at Week 240;
• Proportion of subjects who have a ≥ 1-stage improvement in fibrosis
at Week 48 and Week 240;
• Proportion of subjects who have NASH resolution without worsening
of fibrosis at Week 48 and Week 240.
Inclution Criteria
1) Liver biopsy consistent with NASH (defined as the presence of at
least grade 1 steatosis, hepatocellular ballooning, and lobular
inflammation according to the NAFLD Activity Score [NAS]) and
bridging (F3 fibrosis) according to the NASH CRN classification, in
the opinion of the central reader
a) A historical liver biopsy within 6 months of the Screening visit
may be accepted as the Screening biopsy if the sample is deemed
acceptable for interpretation by the central reader
b) If the subject is deemed ineligible for this study, the liver biopsy,
if performed according to protocol specifications and is within
12 months of the Screening visit, may be used to determine
eligibility for study GS-US-384-1944
2) Subject has the following laboratory parameters at the Screening
visit, as determined by the central laboratory:
a) Alanine aminotransferase (ALT) ≤ 8 x ULN
b) Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as
calculated by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is
unable to be resulted)
d) Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as
Gilbert’s syndrome or hemolytic anemia is present)
e) INR ≤ 1.4, unless due to therapeutic anti-coagulation
f) Platelet count ≥ 100,000/μL
Exclusion Criteria
1) Prior history of decompensated liver disease including ascites, HE, or variceal bleeding
2) CP score > 6, as determined at Screening, unless due to therapeutic anti-coagulation
3) MELD score > 12, as determined at Screening, unless due to therapeutic anti-coagulation
4) Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
5) Chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid [HCV RNA] positive).
Subjects cured of HCV infection less than 5 years prior to the Screening visit are not eligible
6) Other causes of liver disease including, but not limited to, alcoholic
liver disease, hepatitis B, hepatitis C, autoimmune disorders (e.g.,
primary biliary cholangitis, primary sclerosing cholangitis, and
autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,
iron overload, and alpha-1-antitryspin deficiency, based on medical
history and/or centralized review of liver histology
7) History of liver transplantation
8) Current or history of HCC
9) Any weight reduction surgery in the 2 years prior to Screening or
planned during study (weight reduction surgery is disallowed during
the study), and malabsorptive weight loss surgery (e.g., Roux-en-Y or
distal gastric bypass) at any time prior to Screening
10) Weight loss > 10% within 6 months of Screening
11) Human immunodeficiency virus (HIV) infection
12) Unstable cardiovascular disease
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
800 participants
